Computer Systems Validation
2 days ago
Description Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. As a Specialist, QA (CGT) at Lonza, you will support day-to-day Quality Assurance activities in accordance with approved SOPs and policies for a multi-product, cGxP contract manufacturing facility. You will play a key role in providing QA oversight for operations, compliance, and documentation, ensuring that products meet the highest quality standards and are released on time. Benefits An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Daily company bus from the MRT location near your home to and from the Tuas site. Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums. Access to Lonza's full global benefits portfolio: Responsibilities Review executed batch records, logbooks, and documentation to ensure compliance with cGMP and GDocP. Compile lot genealogy and disposition packages to drive timely product release. Provide QA oversight for product status, shipping documents, and quality tag-out systems. Support and approve deviation investigations, CAPA implementation, and timely closure of quality events. Oversee and approve changes to operational documents (e.g., MBRs, SOPs, Forms, Logbooks). Participate in QA shopfloor activities, changeovers, walkdowns, and audits (regulatory/customer). Lead and coordinate site projects, investigations, and change controls as needed. Qualifications Degree or Diploma in Science or Engineering. Experience in Quality Assurance within a cGMP manufacturing environment, ideally in Cell and Gene Therapy (CGT) or biopharmaceuticals. Strong knowledge of cGMP, GDocP, and applicable regulatory requirements. Hands‐on experience with batch record review, deviation management, and CAPA implementation. Proven ability to lead investigations, change controls, and cross‐functional projects. Effective communication and stakeholder management skills. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. #J-18808-Ljbffr Industry Other Category Engineering Sub Category Quality Engineering
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